FDA Medical Device Recalls (openFDA)
Synthes USA (HQ), Inc.: Norian CRS Rotary Mixer Cement 10cc sterile
- Recall number
- Z-0269-2010
- Recalling firm
- Synthes USA (HQ), Inc.
- Product
- Norian CRS Rotary Mixer Cement 10cc sterile
- Status
- Terminated
- Initiated
- 2009-09-14
- Posted
- 2009-11-16
- Terminated
- 2010-03-08
- Reason
- Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Autho
- Root cause
- Nonconforming Material/Component
- Action
- The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.
- Quantity
- 15 units
- Distribution
- The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
- Lot, serial or model codes
- Catalog number 614.10.01S. Lot number N996352
- 510(k) numbers
- ["K060445"]
- PMA numbers
- not on file
- Product code
- GXP
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28